Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:
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Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
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Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bridge Induction Arm
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Drug: Buprenorphine Transdermal Matrix Patch
Buprenorphine transdermal patches will be applied at time of induction initiation and removed at 48 hours.
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| Placebo Comparator: Standard Arm
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Other: Sham patch
Bandage applied at time of induction initiation and removed at 48 hours.
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Outcome Measures
Primary Outcome Measures
- Induction withdrawal severity [Days 0 through 4]
Subjective Opioid Withdrawal Scale (SOWS) scores collected during buprenorphine induction. SOWS scores range from 0-64 with higher scores representing worse withdrawal. Mild withdrawal is defined as scores 0-10, moderate as 11-20, and severe as 21+.
Secondary Outcome Measures
- Induction success [Days 0 through 7]
Induction success, a binary defined by fulling all of the following: attendance at 1 week follow up (yes/no) buprenorphine in urine at initial follow up (positive/negative on urine drug screening) and absence of precipitated withdrawal (yes/no)
- Treatment adherence [Days 0 through delivery]
defined as percent of urine drug screens positive for buprenorphine throughout pregnancy
- Recovery success [Days 0 through delivery]
defined as percent of urine drug screens negative for non-prescribed opioids during prenatal care
Eligibility Criteria
Criteria
Inclusion Criteria:
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Viable pregnancy
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Meet diagnostic criteria for opioid use disorder
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Receive prenatal care through opioid use disorder specific clinic at our institution
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Opioid use within 24 hours prior to presentation
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Desire treatment with buprenorphine
Exclusion Criteria:
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Patients already receiving treatment for opioid use disorder
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History of prior induction attempt with buprenorphine
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Active withdrawal at time of presentation
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Medical contraindication to buprenorphine
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Requiring immediate hospitalization
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Jeannie C Kelly, MD, MS, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202209093